Safety Study of Calcineurin Inhibitor Free GvHD Prophylaxis in Allogeneic Stem Cell Transplantation

NCT ID: NCT00856505

Last Updated: 2009-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2011-03-31

Brief Summary

In stem cell transplantation as treatment for malignant diseases, calcineurin inhibitors like cyclosporine A are commonly used to prevent tissue destruction (GvHD) by activated donor immune cells. The hypothesis for this study is, that replacing calcineurin inhibitors by everolimus and mycophenolate as GvHD prophylaxis not only reduces toxicity of the treatment but also improves tolerance induction of the donor T cells toward the host, eventually increasing the safety of stem cell transplantation.

Conditions

Hematologic Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Everolimus and mycophenolate sodium

Combination of experimental immunosuppressants for GvHD prophylaxis

Group Type: EXPERIMENTAL

Everolimus and mycophenolate sodium

Intervention Type: DRUG

Everolimus tablets, 1.5mg/day bid, dosage adjusted to plasma levels Mycophenolate sodium, 720mg/day bid Duration: Mycophenolate tapering starts at day 56 after stem cell transplantation Everolimus tapering starts at day 100 after stem cell transplantation if no GvHD evident

Interventions

Everolimus and mycophenolate sodium

Everolimus tablets, 1.5mg/day bid, dosage adjusted to plasma levels Mycophenolate sodium, 720mg/day bid Duration: Mycophenolate tapering starts at day 56 after stem cell transplantation Everolimus tapering starts at day 100 after stem cell transplantation if no GvHD evident

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of hematologic malignancies, indicated for allogeneic stem cell transplantation:
• acute myeloid leukemia (AML), in CR1, ≥ CR2, primary refractory, relapse
• chronic myeloid leukemia (CML), in chronic phase, in acceleration or blast crisis
• myelodysplastic syndrome (MDS), RA/RARS (transfusion dependent), RAEB, RAEB-t and CMML
• Lymphoma:

• plasmocytoma
• immunocytoma (M. Waldenström)
• chronic-lymphatic leukemia (CLL)
• additional low and high grade Non-Hodgkin Lymphoma
• Hodgkins disease
• HLA-matched (HLA-A, -B, -DRB1) related or unrelated donor available
• Signed informed consent

Exclusion Criteria

• CNS involvement by underlying disease
• Pulmonary disease with VC < 55%, DLCO < 40%
• Cardiac ejection fraction < 30%, uncontrollable arrhythmia
• Creatinin > 1,5 mg/dl or Creatinin-Clearance < 30 ml/min
• Bilirubin > 2 mg/dl
• Active Hepatitis B or C
• HIV serologic positive
• Pregnancy and lactation
• Pre-menstrual women without medical safe contraception
• Participation on another clinical trial in between 30 days before start or during the study only if the clinical trial interferes with the outcome measures.
• Known allergy to study medication or ingredients of the formulation
• Drug- or alcohol abuse
• Non-compliance

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Freiburg

OTHER

Sponsor Role: lead

Responsible Party

University Hospital Freiburg

Principal Investigators

Juergen Finke, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Freiburg, Div. Hematology/Oncology

Reinhard Marks, MD

Role: STUDY_DIRECTOR

University Medical Center Freiburg, Div. Hematology/Oncology

Locations

University Medical Center, Division Hematology/Oncology

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Reinhard Marks, MD

Role: CONTACT

reinhard.marks@uniklinik-freiburg.de

49-761-270- ext. 3278

Juergen Finke, MD

Role: CONTACT

juergen.finke@uniklinik-freiburg.de

49-761-270- ext. 3408

Facility Contacts

Reinhard Marks, MD

Role: primary

reinhard.marks@uniklinik-freiburg.de

49-761-270 ext. 3278

References

Schafer H, Blumel-Lehmann J, Ihorst G, Bertz H, Wasch R, Zeiser R, Finke J, Marks R. A prospective single-center study on CNI-free GVHD prophylaxis with everolimus plus mycophenolate mofetil in allogeneic HCT. Ann Hematol. 2021 Aug;100(8):2095-2103. doi: 10.1007/s00277-021-04487-y. Epub 2021 Mar 23.

Reference Type: DERIVED

PMID: 33755792 (View on PubMed)

Other Identifiers

00557

Identifier Type: -

Identifier Source: org_study_id